82 Compilation Jobs - Page 4

Roles and Responsibilities Prepare dossiers for regulatory submissions, including compilation of data from various sources into a cohesive document. Review and compile dossiers prepared by others to ensure accuracy and completeness. Coordinate with internal departments (e.g., CMC, Non-Clinical Toxicology) and external vendors/consultants to obtain necessary information for dossier preparation. Ensure timely submission of dossiers to relevant authorities (e.g., FDA, EMA). Maintain accurate records of all correspondence with regulatory agencies. Desired Candidate Profile 5-8 years of experience in Regulatory Affairs or related field (B.Pharma / M.Pharma degree required). Strong understanding o...

Hello all GNU/Linux fans and geeks! Nakshatra Systems is looking forward to hire a Linux Software Repository maintainer, who can service, maintain, upgrade/udpate and manage the software repository. Job is Work from home and contract based. Looking for immediate joiners. Contract job of 1 year. Candidate will have to sign a legal agreement that will include NDA and NCA. Vacancy : 1 Minimum experience needed : 1 - 2 years Mandatory technical skills : ============================= Compiling and creating software from source code. Ability to create software packages using package creation tools to install/remove software. Creating/Updating packages. Keeping track of software dependencies. creat...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

Role & responsibilities Lead the compilation, analysis, and reporting of global management information systems (MIS) and financial performance, ensuring accuracy and consistency across all regions. Review forward-looking financial plans and forecasts from global entities, comparing them with historical trends and actual performance to highlight key variances and business risks. Conduct comprehensive financial analysis across entities and product portfolios, including profitability, cost structures, and operational performance. Report deviations and key insights to senior global management. Design, implement, and continuously improve global cost allocation models and methodologies to ensure f...

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

About The Role This role involves the development and application of engineering practice and knowledge in the following technologiesStandards and protocols, application software and embedded software for wireless and satellite networks, fixed networks and enterprise networks; connected devices (IOT and device engineering), connected applications (5G/ edge, B2X apps); and Telco Cloud, Automation and Edge Compute platforms. This role also involves the integration of network systems and their operations, related to the above technologies. Key Responsibilities: Integrate and customize Yocto-based Linux distributions for embedded platforms. Develop and maintain Linux device drivers for Audio , D...